Kornimate/medical-research-clean huggingface dataset:
nitrite in hypertrophic cardiomyopathy (hcm) study

Conditions: Cardiomyopathy, Hypertrophic

Summary: inorganic nitrate, which is found at high levels in green leafy vegetables, is reduced to nitrite by bacteria in the mouth, swallowed, and absorbed in the stomach into the blood. studies have shown that increasing the blood levels of nitrite improves the way that muscles use oxygen and energy during exercise, and potentially blood flow. some people (\~1 in 500) suffer from a type of genetic heart condition known as hypertrophic cardiomyopathy (hcm). this condition means that the muscle in the heart does not use energy well and becomes larger than average, meaning that they have to tap into the heart's 'energy reserves'. it is not known if nitrite has the same beneficial effects on heart muscle as on other muscles in the body. our study will explore the mechanism by which nitrite may improve the function and energy status of the heart in hcm.


Eligibility criteria:
inclusion criteria: * male or female, aged between 18 and 80 years. * able to provide informed consent. * able to understand basic instructions in english. * a diagnosis of hypertrophic cardiomyopathy based on conventional transthoracic echocardiogram guidelines: left ventricular wall thickness \>1.5cm in the absence of sufficient alternative cause. * exercise limited by symptoms on exertion (nyha class ii symptoms or greater). * peakvo2 \<80% on baseline cpex. * the absence of resting lv outflow tract obstruction (peak gradient \<30 mm hg) on tte. exclusion criteria: * significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety or influence the study outcome. * contraindications for undergoing mri. * hypotension with a systolic blood pressure \<90mmhg. * severe anaemia with a plasma haemoglobin level \<8.0g/dl. * known glucose-6-phosphate dehydrogenase (g6pd) deficiency or g6pd deficiency measured at screening in males of african, asian or mediterranean decent. * female subjects of childbearing potential. * haemodynamically significant valve disease. * predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease.
the effect of chlorella on glycemic control of diabetes

Conditions: Diabetes

Summary: chlorella, a type of unicellular fresh water algae, has been a popular foodstuff in asia, especially in taiwan. recent studies have shown the hypoglycemic effects of chlorella through increasing glucose uptake in the liver and muscle, lowering serum free fatty acid levels, or activation of ppar gamma receptor. however, the hypoglycemic effect in diabetic patients have not been studied. in order to clarify the hypoglycemic effects and mechanism of chlorella in diabetic patients, the investigators conducted a 12-week randomized, double-blind, placebo-control trial on diabetic patients.


Eligibility criteria:
inclusion criteria: * 18-70 years old * type 2 diabetes with less than 2 kinds of oral antidiabetes drugs * hba1c: 7.0-9.0 exclusion criteria: * type 1 diabetes * pregnancy * acute infectious disease * autoimmune disease * hemodynamic unstable
automated hovering for congestive heart failure patients: a pilot study

Conditions: Heart Failure

Summary: this study offers remote monitoring devices for weight and medication adherence, combined with behavioral economic approaches, to patients with congestive heart failure (chf). this pilot study aims to evaluate the feasibility of enrollment processes and intervention roll-out to inform a randomized controlled trial, to estimate the readmission rate of participants, and to assess if and how managing clinicians respond to weight gain alerts entered into a participant's electronic medical record.

the specific aims of this study are: (1) to leverage access to the university of pennsylvania health system (uphs) chf clinic, pennchart (electronic medical record system) resources for identifying eligible patients, and the way to health (wth) platform to launch a pilot study that will inform a randomized controlled trial; (2) to evaluate the feasibility of the enrollment processes and intervention roll-out to inform a randomized controlled trial; (3) to estimate the readmission rate of participants; and, (4) to assess if and how managing physicians respond to weight gain alerts entered into participant charts in pennchart. in this pilot study, no randomization will occur and all participants will receive the intervention.

Eligibility criteria:
inclusion criteria: * discharged to home within the past 30 days from a uphs hospital with a principal diagnosis of chf * aged 18 to 80 years old * will receive follow-up in a uphs outpatient clinic by a cardiologist or primary care physician exclusion criteria: * less than 18 years old or older than 80 years old * will not or cannot provide informed consent * have a markedly shortened life expectancy (listed for heart transplant, have ventricular assist device, are inotrope dependent, have metastatic cancer, or have dementia) * have end-stage renal disease * have a glomerular filtration rate \<25 ml/min * on dialysis * heart failure is managed with a cardiomems monitor * receiving another remote monitoring/telemedicine intervention * receiving follow-up care outside of uphs
the effects of fiber fortified foods to the diets of chronic kidney disease patients

Conditions: Chronic Kidney Disease

Summary: a single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function.

chronic kidney disease (ckd) patients may consume lower than recommended amounts of dietary fiber due to typical dietary habits, dietary restrictions, and uremic symptoms. a progressive decline in kidney function causes an accumulation of uremic molecules that contribute to further progression of the disease and reduced quality of life. in an effort to evaluate the impact of added fiber on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function (egfr ≤ 50 ml/min/1.73 m2), a single blind, six week dietary intervention, clinical trial will be conducted.

Eligibility criteria:
inclusion criteria: participants must: * be 18 years of age or older * have egfr (estimated glomerular filtration rate) of less than 50 ml/min/1.73 m2 (stage 3,4 and 5 but who are not on dialysis) exclusion criteria: participants must not: * have been diagnosed with acute kidney injury (aki) * have been diagnosed with glumerulonephritis (gn) * have been on immunosuppressant/steroid medications * be taking a probiotic supplement and refuse to discontinue it * be scheduled for dialysis within 3 months of study initiation * have a history of liver disease * be on dialysis * have undergone renal transplantation * be breastfeeding * have active gastrointestinal bleeding * have a change in medications over the past 4 weeks

Keywords: chronic kidney disease fiber bun serum creatinine uremic symptoms quality of life
montessori based activities for dementia

Conditions: Dementia

Summary: the objectives of this study are to examine the feasibility of a culturally-adapted group-based montessori method for dementia program in chinese community and examine its effects on engagement and affect in community-dwelling people with dementia.

people who were aged 60 years or over and with mild to moderate dementia were recruited from six community centres and three care homes. participants were randomly assigned to either the intervention group to attend the montessori-based activities or the comparison group to attend the conventional group activities for one hour twice per week over eight weeks. all sessions were videotaped to facilitate analysis. observations of engagement and affect were conducted for each intervention session on the individual participant for a ten-minute period at the beginning, middle, and end of the activity in order to have observations from multiple time points. the menorah park engagement scale and the apparent affect rating scale were used to assess the engagement and affect during the activities based on observations.

Eligibility criteria:
inclusion criteria: * with a diagnosis of dementia at a stage 3 to 5 on the global deterioration scale (gds) exclusion criteria: * were joining any other dementia training activities * would highly likely present a hazard to others through disruptive behaviors * proxy consent could not be obtained

Keywords: person-centered community support
sleep breathing disorders, a main trigger for cardiac arythmias in type i myotonic dystrophy ?

Conditions: Myotonic Dystrophy

Summary: up to one-third of patients with myotonic dystrophy type 1 die suddenly mainly from arrhythmias. sleep apnea is prevalent in myotonic dystrophy (dm1) patients. among the serious complications from sleep apnea, the most alarming are arrhythmias and sudden cardiac death (scd). diagnosis of sleep apnea using simple tools in ambulatory cardiology practice may improve therapy of cardiac arrhythmias in patients with dm1

obstructive sleep apnea (osa) and central sleep apnea (csa), the most common form of sleep disordered breathing (sdb), are prevalent in patients with myotonic dystrophy type 1 (dm1). among the serious complications from sleep apnea, the most alarming are cardiovascular, including arrhythmias and sudden cardiac death (scd). diagnosis of sdb using simple tools in ambulatory cardiology practice may lead to an important primary or additional therapy to supplement the use of drugs or devices in the treatment of cardiac arrhythmias. we hypothesize that dm1 patients with severe oxygen desaturations (oxygen desaturation index \>15/hour of sleep and/or cumulative time spent below 90% of sao2 above 5% of time of recording) will exhibit three fold more nocturnal arrhythmias compared to dm1 group without oxygen desaturations during sleep. during this project we will address the following aims: * is there a relationship between the severity of oxygen desaturations during sleep and nocturnal arrhythmias? we will address this question in a prospective study with seven nights of at home recordings with a multimodal holter ekg assessing together arrhythmias, thoracic impedance (in order to estimate respiratory movements) and sao2. * the specific proarrhythmic role of rem sleep will be assessed during a single night full polysomnography and multiple sleep latency tests (mslt).

Eligibility criteria:
inclusion criteria: * patients suffering from myotonic dystrophy (dm1) * dm1 patients participating in the clinical cohorts of grenoble, saint-etienne and montpellier. * patients implanted or not with pacing devices or cardioverter-defibrillator (icd). * patients treated or not by non invasive ventilation (niv) at home. as a majority, of the patients with dm1 are poorly adherent with niv they continue to exhibit significant desaturation during night. truly compliant patients (mean daily duration\>6/h night) will be studied as a predefined subgroup to assess the protective effect of niv for suppressing oxygen desaturations and avoiding occurrence of nocturnal arrhythmias. exclusion criteria: * patients who have had an acute episode of respiratory failure in the previous month * incapacitated patients in accordance with article l 1121-6 of the public health code
densah burs vs. electrical mallet in closed sinus lifting.

Conditions: Alveolar Bone Loss

Summary: the aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using osseodensification burs versus electrical mallet.

extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge. decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. one of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled. electrical mallet was introduced to overcome (bppv) as it applies controlled force (dan) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation . controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation osseodensification burs now show great outcomes in closed sinus lifting procedure. densah burs increase the density of alveolar bone which increase the primary stability of dental implants . aim of this study is to compare electrical mallet with osseodensification burs in closed sinus lifting.

Eligibility criteria:
inclusion criteria: * patients with partially edentulous posterior maxilla * residual bone height ≥ 5mm * oral hygiene : fair oral hygiene exclusion criteria: * smoking * systematic disease that affects bone remodeling (e.g. uncontrolled diabetes mellitus or osteoporosis) * radiotherapy to head and neck or chemotherapy * chronic disease of maxillary sinus

Keywords: sinus lift electrical mallet osseodensification bone density
lupus intervention for fatigue trial

Conditions: Fatigue; Physical Activity; Lupus Erythematosus, Systemic

Summary: participants in the chicago lupus database or individuals seen at northwestern medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (sle). the intervention group will receive individual coaching sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to sle self-management educational sessions.this study is designed to evaluate the lift intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with sle.

participants in the chicago lupus database or individuals seen at northwestern medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (sle). the intervention group will receive individual coaching based in motivational interviewing sessions focusing on physical activity and nutrition while the control group will receive individual calls focusing on sle self-management. this study is designed to evaluate the lift intervention to decreased fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with sle.

Eligibility criteria:
inclusion criteria: * include meeting at least 4 of 11 american college of rheumatology (acr) classification criteria for definite sle, or 3 out of 11 acr classification criteria with also meeting at least one slicc criteria * be at least 18 years of age * have a bmi between 18-40 kg/m2 * be able to ambulate at least household distances (50ft) * be able to provide informed consent. * be able to speak and read english exclusion criteria: * include pregnancy at baseline * not meeting inclusion criteria.

Keywords: fatigue, physical activity, lupus
study to assess the safety of gsk biologicals' liquid human rotavirus vaccine in healthy infants

Conditions: Infections, Rotavirus

Summary: the purpose of this study is to assess the reactogenicity and safety of gsk biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * a male or female infant of chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after a gestation period of 36 to 42 weeks inclusive. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth (for corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day. inhaled and topical steroids are allowed). * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations. * any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment.. * history of confirmed rotavirus gastroenteritis. * gastroenteritis within 7 days preceding the study vaccine or placebo administration. * previous vaccination with rotavirus vaccine or planned to use during the study period. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Keywords: human rotavirus vaccine
oral tranexamic acid and laser for treatment of melasma

Conditions: Melasma

Summary: tranexamic acid and 1927 diode laser non-ablative fractionated laser for the treatment of melasma.

seeking healthy non-smoking male and female volunteers of all skin types of age 18 to 50 with moderate melasma or severe melasma. participants will receive up to 5 monthly laser treatments to half the face and need to take a pill twice a day for 4 months. follow up visits are required 1 month, 3 months and 6 months after the final treatment. compensation of up to $150 will be provided based on completed visits.

Eligibility criteria:
inclusion criteria: age 18 to 50 skin types i through vi (all skin types) moderate or severe melasma exclusion criteria: pregnant or nursing women current use of hormonal birth control medication or any hormonal therapy use of topical steroids within 1 month of study enrollment use of topical hydroquinone within 3 months of study enrollment history of laser or dermabrasion to the face within 6 months of study enrollment regular use of tanning parlors occupation involving primarily outdoor activities current treatment with blood thinning medications history of thrombosis or thrombophilia history of thromboembolic disease, such as deep vein thrombosis, pulmonary embolism and/or cerebral thrombosis family history of thromboembolic disease history of stroke history of \>2 spontaneous abortions history of kidney dysfunction history of cancer smoking significant cardiovascular or respiratory disease (end-stage congestive heart failure or chronic obstructive pulmonary disease) history of subarachnoid hemorrhage history of acquired disturbances of color vision known allergy to tranexamic acid as per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Keywords: melasma chloasma tranexamic acid nonablative laser resurfacing sunscreen hyperpigmentation
role of cardiac angiomr in diagnosis of cardiac and vascular anomalies in adult patients with turner syndrome

Conditions: Anomaly Heart; Turner Syndrome

Summary: considering the high prevalence of cardiovascular disease in turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. from the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and mri are interrupted at the diaphragmatic level.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of turner syndrome * patients underwent angiomr 1.5 t * age \> 18 years
dose escalation study with bispecific antibodies in adult patients with lupus nephritis

Conditions: Lupus Nephritis (LN)

Summary: this study is researching a particular group of experimental drugs administered for a short period in the treatment of patients with lupus nephritis (ln). the main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up. this is a main study, called an umbrella study, which includes several independent smaller sub-studies. each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating ln. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility criteria:
key general inclusion criteria: 1. diagnosis of systemic lupus erythematosus (sle) and ln, as described in the protocol 2. participant must have refractory or relapsed disease, as described in the protocol key general exclusion criteria: 1. history of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization 2. active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening 3. catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening note: other protocol defined inclusion/exclusion criteria apply

Keywords: bispecific antibodies (bsab) double-stranded dna (dsdna) ln class iii or iv systemic lupus erythematosus (sle)
a study to compare the pharmacokinetics of fimasartan/atorvastatin combination tablet

Conditions: Hypertension; Hyperlipidemia

Summary: a phase i, open-label, randomized, single-dose, 2 x 2 crossover study to compare the pharmacokinetics of fimasartan/atorvastatin combination tablet and coadministration of fimasartan and atorvastatin as individual tablets in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * a healthy male subject, aged 19- 50 years exclusion criteria: * history of clinically significant hypersensitivity to study drug, any other drug * hypotension or hypertension * active liver disease * history of gastrointestinal disease * history of excessive alcohol abuse * participation in any other study within 3 months